• Celator Pharmaceuticals Inc., of Princeton, N.J., said the first patient has been treated in a randomized Phase II study of CPX-351, a liposomal formulation of cytarabine and daunorubicin delivered in a 5:1 molar ratio, in patients with newly diagnosed acute myeloid leukemia. The molar ratios are maintained in patients through Celator's proprietary CombiPlex technology platform. The study is designed to compare CPX-351 to the conventional method of administering cytarabine and daunorubicin. The primary endpoint of the study is complete remission rate. Secondary endpoints are duration of complete remission; time to treatment failure; survival at 12 months, 30-, 60- and 90-day mortality; and safety and tolerability.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., said it completed patient enrollment in its Phase II trial of Droxidopa, an orally active synthetic precursor of norepinephrine, in patients with intradialytic hypotension (IDH). The study will compare the change in mean blood pressure and symptomatic improvement during the final two weeks of treatment to baseline established prior to drug treatment.

• Elixir Pharmaceuticals Inc., of Cambridge, Mass., announced positive results from a pivotal Phase III study of the oral formulation of mitiglinide administered in combination with metformin for the treatment of patients with Type II diabetes. The study achieved statistical and clinical significance in its primary efficacy endpoint. Patients receiving the combination of twice-daily mitiglinide and metformin experienced a statistically significant additional reduction in hemoglobin A1c (HbA1c) levels compared to patients receiving metformin alone. The final results will be submitted for presentation to an upcoming national scientific meeting.

• ImClone Systems Inc., of New York, said its disease-directed randomized Phase II trial of IMC-A12, a fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in patients with previously treated HER2-expressing locally advanced or metastatic breast cancer has commenced patient enrollment. The primary objective of the study is to evaluate the antitumor activity of the combination of capecitabine and lapatinib with and without IMC-A12 in patients with HER2-expressing stages IIIB, IIIC or IV breast cancer that has progressed on trastuzumab-containing treatment. The primary endpoint of the study is progression-free survival.

• Memory Pharmaceuticals Corp., of Montvale, N.J., said it achieved the enrollment goal of 212 patients for its Phase II trial of R3487/MEM 3454, its lead alpha-7 nicotinic receptor agonist in cognitive impairment associated with schizophrenia (CIAS), triggering a $5 million payment from its partner F. Hoffmann La Roche Ltd., of Basel, Switzerland. The primary objective of the trial is to assess the effectiveness of R3487/MEM 3454 in CIAS using the MATRICS Consensus Cognitive Battery. Secondary objectives include assessing the effectiveness of the drug to improve other symptoms of schizophrenia and functional capacity. Memory expects to report top-line results from the trial by the end of April 2009.

• Metabolex Inc., of Hayward, Calif., reported positive results from a randomized, double-blind, placebo-controlled Phase II trial of MBX-8025, an oral drug candidate for the treatment of dyslipidemia. The drug significantly reduced both triglycerides level and LDL cholesterol level compared to placebo after eight weeks of treatment. The triglyceride-lowering effect of MBX-8025 was observed in combination with atorvastatin (Lipitor, Pfizer Inc.) without raising LDL cholesterol. Additionally, MBX-8025 selectively and substantially depleted the small, dense LDL cholesterol particles, both alone and in combination with Lipitor. All results were presented at the World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension in Barcelona, Spain.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., is starting the NEXUS-1 and NEXUS-2 Phase III trials of NX-1207 in benign prostatic hyperplasia. The studies are expected to enroll more than 800 subjects. In Phase II trials to date, the drug has been shown to be safe and efficacious in BPH treatment, with a single administration of NX-1207 producing average improvements in the standardized BPH symptom score that were about double that reported for currently approved BPH drugs.

• Oxford BioMedica, of Oxford, UK, revealed promising additional results from the low-dose cohort of patients in the Phase I/II trial of its gene therapy ProSavin for the treatment of Parkinson's disease. The three patients in the cohort showed improved motor function, as measured by the Unified Parkinson's Disease Rating Score in the "off" state, of an average of 30 percent at six months. The robust safety profile was maintained at six months with no evidence of adverse events or immunologic reactions. In addition, all patients showed improvement in quality of life, as measured by the industry-standard PDQ-39 questionnaire, at six months.

• Pervasis Therapeutics Inc., of Cambridge, Mass., said results from Phase I and II trials of Vascugel, a allogeneic cell therapy product that may restore natural repair and regeneration pathways in the vasculature, indicated that it improved patency and extended time to first intervention in patients with end-stage renal disease who need permanent arteriovenous (AV) access for dialysis compared to placebo. Data also showed that treatment with Vascugel resulted in accelerated vein remodeling for patients receiving an AV fistula and increased lumen diameter for patients receiving an AV graft compared to placebo. The data were presented at the 35th Annual VEITHsymposium in New York.

• Sosei Group Corp., of Tokyo, and NeuroDiscovery Ltd., of Perth, Australia, reported that NeuroSolutions Ltd., a wholly owned subsidiary of NeuroDiscovery, is presenting further pivotal preclinical efficacy data for NSL-043/SD118, which is a potential therapy for neuropathic pain and has successfully completed Phase I studies and is now ready for Phase II. The preclinical data confirmed that the compound may be effective in treating neuropathic pain in man. Those data were presented at the Society for Neuroscience's 38th annual meeting in Washington.

• Titan Pharmaceuticals Inc., of South San Francisco, presented Phase III data in which Probuphine in the treatment of opioid addiction showed a clinically and statistically significant difference over placebo by consistently meeting the primary and secondary endpoints for cumulative distribution function of a percentage of urines at weeks 1-16, weeks 17-24, and weeks 1-24. Topline data were released previously. Titan also said interim data from an ongoing open-label Phase III trial of Probuphine implants indicated that there have been no serious adverse events, and that Probuphine is safe and well tolerated. Data were presented at the annual meeting for the International Society of Addiction Medicine Congress in Cape Town, South Africa.